BEUDAMED
    FDA Adverse Event Injury Summary report: N

    F/G WINGSPAN STENT SYSTEM 2.5 X 9MM

    MDR report key: 3071406 · Received April 22, 2013

    Report

    Report Number
    3008853977-2013-00110
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    November 20, 2009
    Report Date
    April 12, 2013
    Manufacturer
    STRYKER NEUROVASCULAR-CALIF
    Product Code
    NJE
    PMA / PMN Number
    H050001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS PREVIOUSLY REPORTED UNDER MANUFACTURER REPORT NUMBER 2939204-2012-00091. (B)(6). THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS UPON ITS RELEASE. THE DEVICE REMAINS IMPLANTED SO WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. RESTENOSIS AND STENT THROMBOSIS ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE WAS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A REINTERVENTION PROCEDURE, IN-STENT THROMBOSIS WAS OBSERVED. THE PATIENT OUTCOME IS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173072 F/G WINGSPAN STENT SYSTEM 2.5 X 9MM STENT, INTRACRANIAL NEUROVASCULAR NJE STRYKER NEUROVASCULAR-CALIF 12034764

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other 2 GATEWAY BALLOONS (BOSTON SCIENTIFIC)